Home Medicine Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
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Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool

  • John P. Campbell EMAIL logo , Jennifer L.J. Heaney , Meena Shemar , Dene Baldwin , Ann E. Griffin , Emma Oldridge , Margaret Goodall , Zaheer Afzal , Tim Plant , Mark Cobbold , Roy Jefferis , Joannes F.M. Jacobs , Christopher Hand and Mark T. Drayson
Published/Copyright: August 9, 2016
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 3

Abstract

Background:

Serum free light chains (FLC) are sensitive biomarkers used for the diagnosis and management of plasma cell dyscrasias, such as multiple myeloma (MM), and are central to clinical screening algorithms and therapy response criteria. We have developed a portable, near-patient, lateral-flow test (Seralite®) that quantitates serum FLC in 10 min, and is designed to eliminate sample processing delays and accelerate decision-making in the clinic.

Methods:

Assay interference, imprecision, lot-to-lot variability, linearity, and the utility of a competitive-inhibition design for the elimination of antigen-excess (‘hook effect’) were assessed. Reference ranges were calculated from 91 healthy donor sera. Preliminary clinical validation was conducted by retrospective analysis of sera from 329 patients. Quantitative and diagnostic results were compared to Freelite®.

Results:

Seralite® gave a broad competitive-inhibition calibration curve from below 2.5 mg/L to above 200 mg/L, provided good assay linearity (between 1.6 and 208.7 mg/L for κ FLC and between 3.5 and 249.7 mg/L for λ FLC) and sensitivity (1.4 mg/L for κ FLC and 1.7 mg/L for λ FLC), and eliminated anomalous results from antigen-excess. Seralite® gave good diagnostic concordance with Freelite® (Roche Hitachi Cobas C501) identifying an abnormal FLC ratio and FLC difference in 209 patients with newly diagnosed MM and differentiating these patients from normal healthy donors with polyclonal FLC.

Conclusions:

Seralite® sensitively quantitates FLC and rapidly identifies clinical conditions where FLC are abnormal, including MM.

Keywords: free light chains; multiple myeloma; near-patient testing

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: Seralite® development was funded by Abingdon Health Ltd. J.H. receives research funding from Abingdon Health Ltd.

  3. Employment or leadership: M.S., A.G., E.O. and D.B. are, or were, employees of Abingdon Health Ltd. M.D. has, and R.J. has previously had, an advisory role with Abingdon Health Ltd. J.C., M.G., R.J., M.C., T.P., C.H. and M.D. have shares in Abingdon Health Ltd.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision to submit the report for publication.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2016-0194) offers supplementary material, available to authorized users.

Received: 2016-3-8
Accepted: 2016-7-7
Published Online: 2016-8-9
Published in Print: 2017-3-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2016-0194
Keywords for this article
free light chains; multiple myeloma; near-patient testing

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Targeting errors in microbiology: the case of the Gram stain
  4. Time for a holistic approach and standardization education in laboratory medicine
  5. Reviews
  6. Serum uric acid levels and risk of prehypertension: a meta-analysis
  7. Lactic acidosis: an update
  8. Mini Review
  9. Progress and impact of enzyme measurement standardization
  10. Opinion Paper
  11. Critical comments to a recent EFLM recommendation for the review of reference intervals
  12. IFCC Paper
  13. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project
  14. Genetics and Molecular Diagnostics
  15. Evaluation and comparison of three assays for molecular detection of spinal muscular atrophy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Risk analysis of the preanalytical process based on quality indicators data
  18. Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
  19. Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests
  20. Next-generation osmotic gradient ektacytometry for the diagnosis of hereditary spherocytosis: interlaboratory method validation and experience
  21. Diagnosis of sphingolipidoses: a new simultaneous measurement of lysosphingolipids by LC-MS/MS
  22. Monitoring nicotine intake from e-cigarettes: measurement of parent drug and metabolites in oral fluid and plasma
  23. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
  24. A real-world evidence-based approach to laboratory reorganization using e-Valuate benchmarking data
  25. Cancer Diagnostics
  26. Utility of proGRP as a tumor marker in the medullary thyroid carcinoma
  27. Cardiovascular Diseases
  28. Can non-cholesterol sterols and lipoprotein subclasses distribution predict different patterns of cholesterol metabolism and statin therapy response?
  29. Infectious Diseases
  30. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
  31. Diabetes
  32. Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients
  33. Corrigendum
  34. EFLM Recommendation
  35. Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
  36. Letters to the Editor
  37. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
  38. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
  39. Mixing studies for abnormal coagulation screen – the current trend
  40. Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
  41. How to define reference intervals to rule in healthy individuals for clinical trials?
  42. Evaluation of the performance of INDEXOR® in the archive unit of a clinical laboratory: a step to Lean laboratory
  43. Evaluation of an automated chemiluminescent immunoassay for salivary cortisol measurement. Utility in the diagnosis of Cushing’s syndrome
  44. Analysis of hemolysis, icterus and lipemia in arterial blood gas specimens
  45. Comparison of three routine insulin immunoassays: implications for assessment of insulin sensitivity and response
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